JP6925211B2 - Compression molding - Google Patents

Description

The present invention relates to a compression-molded preparation containing a protein and / or peptide-containing extract derived from an animal and / or a plant.

Protein is counted as one of the three major nutrients, and in addition to being a material that constitutes a living body, it also plays a role as an energy source.
So far, many products containing proteins, peptides that decompose proteins, and amino acids have been developed for the purpose of supplementing proteins. Typical examples are beverages, jellies, tablets, granules and the like. Among the pharmaceutical forms, the compression-molded formulation is excellent in portability and storage stability, and is a suitable form suitable for oral ingestion, which can be easily ingested in a small amount at a time.

It is known that the compression-molded preparation may cause a change in appearance such as discoloration or coloring or spots during storage due to chemical interaction of the contained components or the like. The two are distinguished from each other because the color change and the occurrence of spots of these preparations can occur separately. For example, it has been reported that when vitamin C and iron come into contact with each other, browning and black spots of tablets occur, and by coating each of them to avoid direct contact, browning and black spots are suppressed (Patent Document 1). Has been done. In addition, it has been reported that when tablets containing absorbable amino acids are stored, spots occur and browning occurs, and silicates are combined with absorbable amino acids to suppress these (Patent Document 2).
On the other hand, in the compression-molded preparation containing the protein and / or peptide-containing extract derived from animals and / or plants, the appearance change such as the color tone change of the preparation and the occurrence of spots due to storage is not observed.

Japanese Unexamined Patent Publication No. 2013-179905 Japanese Unexamined Patent Publication No. 2014-47182

However, when the present inventor blends an organic acid such as ascorbic acid to improve the flavor of a compression-molded preparation containing a protein and / or peptide-containing extract derived from animals and / or plants, spots are formed on the surface of the preparation during storage. Was found to appear. The appearance of these spots was confirmed in the preparation containing a protein or peptide containing a large amount of a predetermined amino acid such as arginine as a constituent amino acid. Conventionally, it has been known to coat the spots on the surface of the pharmaceutical product with a sugar coating or the like, but since the work process becomes complicated, a method for easily avoiding quality problems has been desired.
Therefore, the present invention relates to providing a compression-molded preparation containing a protein and / or peptide containing a large amount of a predetermined amino acid such as arginine as a constituent amino acid and suppressing the occurrence of spots on the surface of the preparation during storage.

As a result of diligent studies to solve the above problems, the present inventor has found that the use of adipic acid, tartaric acid, malic acid or citric acid among organic acids does not cause spots on the surface of the preparation during storage. I found it.

That is, the present invention describes the following components (A) and (B):
(A) Animal and / or plant-derived protein and / or peptide-containing extract that meets the following conditions: Protein and / or peptide content of 1% by mass or more and less than 25% by mass Protein and / or peptide contains arginine, histidine, glutamic acid and tryptophan. Containing as a constituent amino acid, and the total amount of arginine, histidine, glutamic acid and tryptophan per 100 g of protein and / or peptide is 25 g or more and 48.5 g or less (B) Adipic acid and / or tartrate 1% by mass or more and 4% by mass or less. It provides a compression-molded formulation containing it.
Further, in the present invention, the following components (A ¹ ) and (C):
(A ¹ ) Animal and / or plant-derived protein and / or peptide-containing extract that meets the following conditions: 1% by mass or more and less than 25% by mass of lipid content of protein and / or peptide is arginine, histidine, glutamate and tryptophan As a constituent amino acid, and the total amount of arginine, histidine, glutamic acid and tryptophan per 100 g of protein and / or peptide is 25 g or more and 32 g or less (C) apple acid and / or citric acid 1% by mass or more and 4% by mass or less. It provides a compression-molded formulation containing it.

The compression-molded preparation of the present invention contains an organic acid in addition to a protein and / or peptide-containing extract derived from animals and / or plants, and while improving the flavor of the preparation, spotting occurs on the surface of the preparation during storage. Is suppressed and stable over time.

The compression-molded preparation of the present invention has (A) an animal-and / or plant-derived protein and / or peptide-containing extract that satisfies the following conditions. The lipid content is 1% by mass or more and less than 25% by mass. The protein and peptide are arginine. Histidine, glutamic acid and tryptophan are contained as constituent amino acids, and the total amount of arginine, histidine, glutamic acid and tryptophan per 100 g of protein and / or peptide is 25 g or more and 48.5 g or less, and (B) adipic acid and / or tartrate acid. contains.

The type of protein is not particularly limited, and examples thereof include animal-derived proteins such as milk protein, egg protein, animal meat protein, collagen, and gelatin; and plant-derived proteins such as soybean protein, pea protein, wheat protein, and rice protein. ..
Examples of milk proteins include casein and the like.
Examples of the egg protein include egg yolk protein and egg white protein.
Examples of animal meat proteins include proteins derived from livestock meat such as beef, pig, horse, sheep and rabbit, poultry meat such as chicken and turkey, and fish meat such as sardine.
Examples of peptides include hydrolysates and enzymatic degradation products of the animal-derived protein or plant-derived protein, products obtained by fermentation, and peptides purified or isolated from them.
Among them, wheat protein, soybean protein, and milk protein are preferable because they contain arginine, histidine, glutamic acid, and tryptophan as constituent amino acids in a high ratio.
The molecular weights of proteins and peptides are not particularly limited.

(A) The content of lipid in the protein and / or peptide-containing extract derived from animals and / or plants is 1% by mass or more and less than 25% by mass. From the viewpoint of effectively exerting the effect of the present invention and from the viewpoint of compression molding formulation, the lipid content is preferably 1.1% by mass or more, more preferably 1.2% by mass or more. Further, from the viewpoint of good flavor, it is less than 25% by mass, more preferably 15% by mass or less, still more preferably 10% by mass or less.

The protein and peptide (A) contain arginine, histidine, glutamic acid and tryptophan as constituent amino acids. The total amount of arginine, histidine, glutamic acid and tryptophan per 100 g of the protein and / or peptide is 25 g or more and 48.5 g or less. As shown in Examples below, when a protein or peptide-containing extract containing a large amount of a predetermined amino acid such as arginine as a constituent amino acid was made into a compression-molded preparation by adding ascorbic acid, spots appeared on the surface of the preparation during storage.
The total amount of arginine, histidine, glutamic acid and tryptophan per 100 g of protein and / or peptide is 25 g or more, more preferably 26 g or more, and more preferably 26 g or more per 100 g of protein and / or peptide from the viewpoint of the number of spots appearing on the surface of the preparation. It is preferably 27 g or more, 48.5 g or less, more preferably 46 g or less, and further preferably 44 g or less.

The amount of arginine per 100 g of the protein and / or peptide of (A) is preferably 3 g or more, more preferably 3.5 g or more, further preferably 3.7 g or more, and preferably 10 g or less, more preferably 9 It is 5.5 g or less, more preferably 9 g or less.
The amount of histidine per 100 g of the protein and / or peptide of (A) is preferably 2 g or more, more preferably 2.3 g or more, still more preferably 2.5 g or more, and preferably 3.5 g or less, more preferably. Is 3.3 g or less, more preferably 3.2 g or less.
The amount of glutamic acid per 100 g of the protein and / or peptide of (A) is preferably 18 g or more, more preferably 18.5 g or more, still more preferably 19 g or more, and preferably 42 g or less, more preferably 40 g or less. More preferably, it is 35 g or less.
The amount of tryptophan per 100 g of the protein and / or peptide of (A) is preferably 0.9 g or more, more preferably 1.0 g or more, further preferably 1.2 g or more, and preferably 1.5 g or less. It is more preferably 1.45 g or less, still more preferably 1.4 g or less.
The constituent amino acids other than arginine, histidine, glutamic acid and tryptophan are not particularly limited, but when ascorbic acid is added, spots are more likely to occur when a large amount of methionine is contained as a constituent amino acid, so that the effect of the present invention is effectively exhibited. From this point of view, the amount of methionine per 100 g of the protein and / or peptide of (A) is preferably 1 g or more, more preferably 1.2 g or more, still more preferably 1.3 g or more, and preferably 3 g or less. It is more preferably 2.8 g or less, still more preferably 2.6 g or less.
Glutamine is converted to glutamic acid by hydrolysis of the protein in the pretreatment of amino acid analysis, and glutamine and glutamic acid in the protein cannot be distinguished by measurement. Therefore, in this specification, the amount of glutamic acid is defined as the sum of the amounts of glutamine and glutamic acid.
Similarly, aspartic acid is the sum of aspartic acid and aspartic acid.

(A) The content of the protein and / or peptide in the protein and / or peptide-containing extract derived from animals and / or plants is preferably 10% by mass or more and 90% by mass or less, more preferably, from the viewpoint of expressing a physiological effect. Is 30% by mass or more and 75% by mass or less.

(A) An animal and / or plant-derived protein and / or peptide-containing extract can be obtained by using a known method and extracting from, for example, eggs, milk, cereals, etc., and the extraction conditions are also set. It can be set as appropriate. Commercially available products can also be used.

(A) Animal and / or plant-derived protein and / or peptide-containing extracts can be used alone or in combination of two or more.
In the compression-molded preparation of the present invention, the content of (A) animal and / or plant-derived protein and / or peptide-containing extract is preferably 30% by mass or more, 90% by mass or less, and more preferably 40% by mass. As mentioned above, it is 70% by mass or less.

Further, in the compression-molded preparation of the present invention, the content of protein and / or peptide is preferably 10% by mass or more, more preferably 20% by mass or more, still more preferably 30% by mass or more from the viewpoint of exhibiting a physiological effect. From the viewpoint of compression molding formulation, it is preferably 90% by mass or less, more preferably 70% by mass or less, and further preferably 60% by mass or less.
As used herein, the content of protein and / or peptide is the amount of one of the protein and peptide when it is contained, and the total amount when both are contained. The protein and / or peptide content can be measured according to the method described in Examples below.

The compression-molded preparation of the present invention contains (B) adipic acid and / or tartaric acid. (A) A compression-molded preparation containing an animal-and / or plant-derived protein and / or a peptide-containing extract has a bitter taste when it is contained in the mouth. The flavor of the molded product can be improved. Further, with the component (B), spots do not occur on the surface of the compression-molded preparation during storage. Adipic acid and tartaric acid can be used alone or in combination of two.

The content of (B) adipic acid and / or tartaric acid in the compression-molded preparation of the present invention is 1% by mass or more and 4% by mass or less, but is preferably 2 from the viewpoint of good flavor and disintegration. It is 5% by mass or more and 3.5% by mass or less.

In the present invention, the content of (A) animal and / or plant-derived protein and / or peptide-containing extract in the compression-molded preparation with respect to the content of (B) adipic acid and / or tartaric acid in the compression-molded preparation. The ratio (content ratio) [(A) / (B)] is preferably 3.3 or more, more preferably 6.7 or more, still more preferably 10 or more, from the viewpoint of good flavor. It is preferably 30 or less, more preferably 25 or less, still more preferably 23 or less, still more preferably 20 or less.

In addition, the compression-molded preparation of the present invention has a protein and / or peptide-containing extract lipid content of 1% by mass or more and less than 25% by mass of a protein and / or a protein and / or a protein derived from an animal and / or a plant that satisfies the following conditions ^{(A 1).} Alternatively, the peptide contains arginine, histidine, glutamic acid and tryptophan as constituent amino acids, and the total amount of arginine, histidine, glutamic acid and tryptophan per 100 g of protein and / or peptide is 25 g or more and 32 g or less, and (C) malic acid and / Alternatively, it contains citric acid.
(A ¹ ) The type of protein and / or peptide-containing extract derived from animals and / or plants is not particularly limited, and the same components as those in the above component (A) can be mentioned.

(A ¹ ) The content of lipid in the protein and / or peptide-containing extract derived from animals and / or plants is 1% by mass or more and less than 25% by mass. From the viewpoint of effectively exerting the effect of the present invention and from the viewpoint of compression molding formulation, the content of lipid in the protein and peptide is preferably 1.1% by mass or more, more preferably 1.2% by mass. It is less than 25% by mass, more preferably 15% by mass or less, and further preferably 10% by mass or less from the viewpoint of good flavor.

The protein and peptide of (A ¹ ) contain arginine, histidine, glutamic acid and tryptophan as constituent amino acids. The total amount of arginine, histidine, glutamic acid and tryptophan per 100 g of the protein and / or peptide is 25 g or more and 32 g or less. As shown in Examples below, when a protein or peptide containing a large amount of a predetermined amino acid such as arginine as a constituent amino acid was made into a compression-molded preparation by adding ascorbic acid, spots appeared on the surface of the preparation during storage.
The total amount of arginine, histidine, glutamic acid and tryptophan per 100 g of protein and / or peptide is 25 g or more, more preferably 26 g or more, and more preferably 26 g or more per 100 g of protein and / or peptide from the viewpoint of the number of spots appearing on the surface of the preparation. It is preferably 27 g or more, 32 g or less, more preferably 31.5 g or less, and further preferably 31 g or less.

The amount of arginine per 100 g of the protein and / or peptide of (A ¹ ) is preferably 3 g or more, more preferably 3.5 g or more, further preferably 3.6 g or more, still more preferably 3.7 g or more, and also. It is preferably 9.5 g or less, more preferably 9 g or less, still more preferably 8.5 g or less.
The amount of histidine per 100 g of the protein and / or peptide of (A ¹ ) is preferably 2.6 g or more, more preferably 2.7 g or more, still more preferably 2.8 g or more, and preferably 3.3 g or less. , More preferably 3.2 g or less, still more preferably 3.1 g or less, still more preferably 3.0 g or less.
The amount of glutamic acid per 100 g of the protein and / or peptide of (A ¹ ) is preferably 18 g or more, more preferably 18.5 g or more, still more preferably 19 g or more, and preferably 23 g or less, more preferably 22 g or less. , More preferably 21.5 g or less.
The amount of tryptophan per 100 g of the protein and / or peptide of (A ¹ ) is preferably 0.9 g or more, more preferably 1.0 g or more, still more preferably 1.1 g or more, and preferably 1.5 g or less. , More preferably 1.4 g or less, still more preferably 1.3 g or less.
The constituent amino acids other than arginine, histidine, glutamic acid and tryptophan are not particularly limited, but when ascorbic acid is added, spots are more likely to occur when a large amount of methionine is contained as a constituent amino acid, so that the effect of the present invention is effectively exhibited. From this point of view, the ^{amount of methionine per 100 g of the protein and / or peptide of (A 1} ) is preferably 1.0 g or more, more preferably 1.1 g or more, still more preferably 1.2 g or more, and preferably 1.2 g or more. It is 2.9 g or less, more preferably 2.7 g or less, still more preferably 2.5 g or less.

In the present invention, when citric acid is used as the component (C), it is preferable that the protein and / or peptide-containing extract derived from ^{(A 1) animal and / or plant satisfies the following conditions.}
The total amount of arginine, histidine, glutamic acid and tryptophan per 100 g of protein and / or peptide is 25 g or more, more preferably 26 g or more, and more preferably 26 g or more per 100 g of protein and / or peptide from the viewpoint of the number of spots appearing on the surface of the preparation. It is preferably 27 g or more, preferably 32 g or less, more preferably 31.5 g or less, and further preferably 31 g or less.
The amount of arginine per 100 g of protein and / or peptide is preferably 3.5 g or more, more preferably 3.6 g or more, further preferably 3.7 g or more, and preferably 9.5 g or less, more preferably 9 g. Below, it is more preferably 8.5 g or less, still more preferably 4 g or less.
The amount of histidine per 100 g of protein and / or peptide is preferably 2.6 g or more, more preferably 2.8 g or more, still more preferably 3 g or more, and preferably 3.2 g or less, more preferably 3.1 g. It is as follows.
The amount of glutamic acid per 100 g of protein and / or peptide is preferably 18 g or more, more preferably 18.5 g or more, still more preferably 19 g or more, and preferably 23 g or less.
The amount of tryptophan per 100 g of protein and / or peptide is preferably 0.9 g or more, more preferably 1.0 g or more, further preferably 1.2 g or more, and preferably 1.5 g or less, more preferably 1 It is .45 g or less, more preferably 1.4 g or less.

(A ¹ ) Animal and / or plant-derived protein and / or peptide-containing extracts can be used alone or in combination of two or more.
In the compression-molded preparation of the present invention, the ^{content of (A 1} ) animal and / or plant-derived protein and / or peptide-containing extract is preferably 30% by mass or more, 90% by mass or less, and more preferably 40% by mass. % Or more and 70% by mass or less.

Further, the content of protein and / or peptide in the compression-molded preparation containing the component (A ¹ ) of the present invention is preferably 10% by mass or more, more preferably 20% by mass or more, from the viewpoint of exhibiting a physiological effect. It is more preferably 30% by mass or more, and from the viewpoint of compression molding formulation, it is preferably 90% by mass or less, more preferably 70% by mass or less, still more preferably 60% by mass or less.

The compression-molded preparation of the present invention contains (C) malic acid and / or citric acid. (A ¹ ) A compression-molded preparation containing an animal-and / or plant-derived protein and / or a peptide-containing extract has a bitter taste when it is contained in the mouth. The flavor of the compression-molded formulation can be improved. Further, with the component (C), no spots are generated on the surface of the compression-molded preparation during storage. Malic acid and citric acid can be used alone or in combination of two. Malic acid is preferable because it has a good flavor.

The content of (C) malic acid and / or citric acid in the compression-molded preparation of the present invention is 1% by mass or more and 4% by mass or less, but is preferably from the viewpoint of good flavor and disintegration. It is 2% by mass or more and 3.5% by mass or less.

In the present invention, the protein and / or peptide-containing extract ^{of (A 1} ) animal and / or plant origin in the compression-molded preparation with respect to the content of (C) malic acid and / or citric acid in the compression-molded preparation. The content ratio (content mass ratio) [(A ¹ ) / (C)] is preferably 3.3 or more, more preferably 6.7 or more, still more preferably 10 or more, from the viewpoint of good flavor. Also, it is preferably 30 or less, more preferably 25 or less, still more preferably 23 or less, still more preferably 20 or less.

In addition to the above components, the compression-molded preparation of the present invention contains minerals (for example, calcium, magnesium, iron, zinc, chromium, selenium, manganese, molybdenum, copper, iodine, phosphorus) as long as the effects of the present invention are not impaired. , Potassium, sodium), vitamins (eg, vitamin A, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin E, folic acid and their salts, or esters thereof), sweeteners (eg, fructose, glucose, galactose) , Xylose and other monosaccharides; sucrose, lactose, malt sugar, trehalose, isomaltooligosaccharide, galactooligosaccharide, fructo-oligosaccharide, milk fruit oligosaccharide, soybean oligosaccharide, isomalturose, coupling sugar and other small sugars; sugar alcohol, Synthetic sweeteners such as saccharin, sucralose, stevia, and acesulfam potassium), surfactants, fragrances, coloring agents, emulsifiers, preservatives, and the like may be appropriately blended.
The compression-molded preparation of the present invention may contain an organic acid other than the components (B) and (C). The content of the organic acid other than (C) in the compression-molded preparation is 2% by mass or less, further 0.5% by mass or less, and further 0% by mass. In particular, it is preferable that it does not contain ascorbic acid. The content of ascorbic acid in the compression-molded preparation is 1% by mass or less, and further 0% by mass.

The compression-molded preparation of the present invention comprises (A) an animal and / or plant-derived protein and / or peptide-containing extract, (B) adipic acid and / or tartaric acid, and a preparation additive added as needed. It is a formulation produced by compression molding into a certain shape.
In addition, the compression-molded preparation of the present invention is ^{added with (A 1} ) animal and / or plant-derived protein and / or peptide-containing extract, (C) malic acid and / or citric acid, and if necessary. It is a pharmaceutical product produced by compression-molding a pharmaceutical additive into a certain shape.
Specific dosage forms include tablets, troches and the like. Of these, tablets are preferable because they are easy to ingest and are ingested as food. If necessary, the tablet may be coated with a sugar coating, a film coating, or the like, but it is preferable not to coat the tablet from the viewpoint of avoiding the complexity of the work process.
The shape of the compression-molded preparation may be a circular tablet or various irregular shaped tablets having a planar shape such as an ellipse, an oval, or a quadrangle. In the case of a round tablet, a diameter of 5 to 15 mm is preferable from the viewpoint of ease of administration.
The weight of the compression-molded preparation is preferably 0.1 to 2 g per preparation, and more preferably 0.3 to 1 g from the viewpoint of convenience and effectiveness.

Formulation additives used to prepare compression-molded formulations include, for example, excipients (eg, lactose, starches, crystalline cellulose, light anhydrous silicic acid, calcium hydrogen phosphate, etc.), binders (eg, hydroxy). Procylmethyl cellulose, hydroxypropyl cellulose, gelatin, pregelatinized starch, polyvinylpyrrolidone, polyvinyl alcohol, purulan, methylcellulose, hardened oil, etc., disintegrants (eg, carmellose, carmellose calcium, croscarmellose sodium, crospopidone, corn starch, etc. Low-substituted hydroxypropyl cellulose, etc.), lubricants (eg, calcium stearate, magnesium stearate, sodium stearyl fumarate, talc, silicon dioxide, etc.), thickeners, fluidity improvers, bulking agents, dispersants, buffers Agents, diluents and the like can be mentioned.

The compression-molded preparation of the present invention is not particularly limited and is produced according to a conventional method.
For example, the raw material powder may be directly compressed and molded (direct powder compression method), or the granulated product may be compressed by a tableting molding machine and molded (granule compression method). Of these, from the viewpoint of simplicity of the process, it is preferable to use the direct powder compression method to form tablets.
As the granulation method, a cylindrical granulator, a spherical granulator, an extrusion granulation method using a pelleter, a crushing granulation method using a speed mill, a power mill, etc., a rolling granulation method, a stirring granulation method, etc. A fluidized bed granulation method and the like can be mentioned. The average particle size of the granulated product is preferably 45 μm to 850 μm, more preferably 100 μm to 500 μm.
When the compression-molded preparation is produced by directly or compressing the granulated product, a commonly used tableting machine such as a rotary type locking machine or a single-shot type locking machine can be used.

The compression molding pressure at the time of tableting is preferably about 3 to 30 MPa, more preferably about 10 to 20 MPa from the viewpoint of maintaining the hardness of the molded product and disintegrating property.

Further, the tablet hardness is preferably a hardness that can withstand transportation, storage, etc., and is preferably 35 N or more, further 45 N or more, and further 55 N or more in consideration of ease of chewing. The upper limit is 140 N or less, more preferably 90 N or less.

[Protein analysis]
The mass of protein was calculated by multiplying the amount of nitrogen quantified by the combustion method by the nitrogen-protein conversion coefficient. The nitrogen-protein conversion factor is milk: 6.38 and soybean: 5.71. The nitrogen-protein conversion coefficient used to calculate the amount of nitrogen is based on Table 7 of the Standard Tables of Food Composition in Japan, Chapter 1, 2) Listed Ingredients, etc. Conversion factors for foods other than were used.

[Analysis of constituent amino acids]
The mass of the constituent amino acids was determined by the automatic amino acid analysis method.

[Analysis of lipids]
The mass of lipid was determined by the Soxhlet method based on the standard fat and oil analysis test method-2003 edition (established by the Japan Oil Chemists' Society) II standard test method 1 fat and oil raw material and degreased product 1.5 oil content.

[Analysis of organic acids]
1 g of the pharmaceutical product was collected, 20 mL of 5% perchloric acid was added, and the mixture was shaken for 10 minutes for extraction. This was adjusted to 200 mL with water and sonicated for 10 minutes. After filtration, it was subjected to a high performance liquid chromatograph.
<Operating conditions for high performance liquid chromatograph>
Model: LC-20AD (Shimadzu Corporation)
Detector: Ultraviolet-visible absorptiometer SPD-20AV (Shimadzu Corporation)
Column: Sim-pack SCR-102H 300 x 80 (length x inner diameter (mm)) (Shimadzu Corporation)
Column temperature: 40 ° C
Mobile phase: 3 mmоl / L perchloric acid reaction solution: 0.2 mmоl / L containing bromothymol blue 15 mmоl / L disodium hydrogen phosphate solution Flow rate: mobile phase 1.0 mL / min, reaction solution 1.4 mL / min
Measurement wavelength: 445 nm

[material]
The raw materials of the origin and composition shown in Table 1 were used as the protein and / or peptide-containing extracts derived from the animals and / or plants of the components (A) and (A ^1).

(A) Milk protein: casein Na, Armor Proteins S. A. S.
(B) Milk protein: Hokkaido butter milk powder, Yotsuba Dairy Co., Ltd. (c) Wheat protein: NUTRALYS F85M, Rocket Japan (d) Soy protein: SUPROXT 219D IP, DuPont (e) Milk protein: Yogurt powder YPA, Morinaga Dairy Co., Ltd. (f) Wheat protein: NUTRALYSW, Rocket Japan (g) Soy protein: Protein powder, soybean-derived, Wako Junyaku Kogyo Co., Ltd. (h) Milk protein: Whey powder, Morinaga Dairy Co., Ltd.

In addition, the following raw materials were used.
Tartaric acid: L-tartaric acid S, Fuso Chemical Industry Co., Ltd. Adipic acid: Adipic acid, Wako Pure Chemical Industries, Ltd. Malic acid: Malic acid Fusou S, Fuso Chemical Industry Co., Ltd. Citric acid: Purified citric acid anhydrous MS, Fuso Chemical Industry Co., Ltd. Company Ascorbic Acid: L-Ascorbic Acid, HEBEI WELCOME PHARMACEUTICAL Co. LTD
Martinol: Amalti MR-50, Mitsubishi Corporation Food Tech Co., Ltd. Guagam: Neosoft G, Taiyo Kagaku Co., Ltd. Powdered Cellulose: KC Flock W-400G, Nippon Paper Chemicals Co., Ltd. Silicon Dioxide: Carplex FPS-500, DSL Japan Co., Ltd. Company Sucrose fatty acid ester: Ryoto Sugar Ester B-370F, Mitsubishi Chemical Foods Co., Ltd.

Examples 1-42 and Comparative Examples 1-16
[Preparation of tablets]
Each raw material component is uniformly mixed according to the compounding composition shown in Tables 2 to 5, and a ring-shaped punch having a hole diameter of 9 mm is used with a single-shot tableting machine (manufactured by RIKEN) to weigh 350 mg / tablet and 3 MPa. The tablet was tableted with a tableting pressure to obtain a 9 mm circular tablet.

[Preservation test]
The above-mentioned preparations were placed in aluminum bags of 3 tablets each, sealed, and stored at 55 ° C. for 7 days.
After storage, the number of spots appearing on the tablet surface was visually determined, and the spot rate (%) was determined by binarizing the image of the tablet surface.
The results are shown in Tables 2 to 5 as an average of 3 tablets.

As shown in Tables 2 to 5, in Comparative Examples 1 to 8 in which the organic acid was not blended, no spots were observed over time. On the other hand, in Comparative Examples 9 to 15 containing ascorbic acid, many brown spots having a diameter of 0.1 mm to 1 mm were observed. No spots were generated in Comparative Example 8 and Comparative Example 16 containing proteins having a small total amount of arginine, histidine, glutamic acid and tryptophan in the constituent amino acids, regardless of the presence or absence of ascorbic acid. No spots were observed over time in Examples 1 to 42 in which tartaric acid and adipic acid were blended.

Examples 43-57
[Preparation of tablets]
Using malic acid or citric acid, 9 mm round tablets were obtained in the same manner as in Example 1 according to the formulation composition shown in Table 6 or Table 7.

[Preservation test]
For the tablets obtained in Examples 43 to 57, the number of spots appearing on the tablet surface and the spot rate (%) were measured in the same manner as described above.
The results are shown in Tables 6 and 7.

As shown in Tables 6 and 7, in Comparative Examples 9 to 12 in which ascorbic acid was added, many brown spots were observed, but in Examples 43 to 57 in which malic acid and citric acid were added, such spots were found. It did not occur.

Claims (6)

The following components (A) and (B):
(A) Protein and / or peptide-containing extract derived from milk, wheat or soybean that meets the following conditions Lipid content is 1% by mass or more and less than 25% by mass Protein and / or peptide is arginine, histidine, glutamate and tryptophan As a constituent amino acid, and the total amount of arginine, histidine, glutamate and tryptophan per 100 g of protein and / or peptide is 25 g or more and 48.5 g or less (B) Adipic acid and / or tartrate acid 1% by mass or more and 4% by mass or less. A compression molded formulation containing. The compression-molded preparation according to claim 1, wherein the content of the protein and / or peptide is 10% by mass or more and 90% by mass or less. Claimed that protein and / or peptide contains 3 g or more and 10 g or less of arginine, 2 g or more and 3.5 g or less of histidine, 18 g or more and 42 g or less of glutamic acid, and 0.9 g or more and 1.5 g or less of tryptophan per 100 g of protein and / or peptide. Item 3. The compression-molded preparation according to Item 1 or 2. The following components (A ¹ ) and (C):
(A ¹ ) Protein and / or peptide-containing extract derived from milk, wheat or soybean that meets the following conditions Lipid content is 1% by mass or more and less than 25% by mass Protein and / or peptide is arginine, histidine, glutamic acid and It contains tryptophan as a constituent amino acid, and the total amount of arginine, histidine, glutamate and tryptophan per 100 g of protein and / or peptide is 25 g or more and 32 g or less (C) apple acid and / or citric acid 1% by mass or more and 4% by mass or less. A compression molded formulation containing. The compression-molded preparation according to claim 4, wherein the content of the protein and / or peptide is 10% by mass or more and 90% by mass or less. Protein and / or peptide is 3 g or more and 9.5 g or less of arginine, 2.6 g or more and 3.3 g or less of histidine, 18 g or more and 23 g or less of glutamate, 0.9 g or more and 1.5 g of tryptophan per 100 g of protein and / or peptide. The compression-molded preparation according to claim 4 or 5, which includes the following.